FDA criticized for handling of abortion pill safety

Mifeprex already carries a "black box" warning, the agency's
most strident alert, to highlight other safety concerns. The FDA
said Monday that the drug's black box warning will expand.

Serious bacterial infection may happen silently, without typical
signs of infection like fever or tenderness, the label warns.

Women who have taken the drug should contact a doctor
immediately if they suffer fever, abdominal pain and heavy
bleeding, a medication guide aimed at consumers says. And the FDA
counsels women to take their medication guide to speed medical
treatment.

In addition, women who take the pill must sign a patient
agreement pledging to contact a doctor immediately if they have
fever higher than 100.4 degrees that lasts more than four hours or
severe abdominal pain. The women are also warned that heavy
bleeding that soaks two, thick full-sized sanitary pads per hour
for two consecutive hours is cause for contacting a doctor.

According to Danco Laboratories, 360,000 American women have
used the pill since it was approved by the FDA.